Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)

* Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System) * Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep study device results. * Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical population.

Completed

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Health System

Colorado Springs, Colorado, 80909, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Undergoing knee or hip total joint replacement
Answer Yes to any PROSPECT health history questions and/or score Positive on the sleep questionnaires

Exclusion criteria

Tape Allergy
Previous Diagnosis Of Obstructive Sleep Apnea

Treatment and study plan

Primary outcomes

Comparison of objective sleep data to standardized sleep questionnaires

Time frame: Pre and Post Operative

Secondary outcomes

Compare Pre and Post Operative Objective sleep data

Time frame: Pre and post operative

Sponsors and collaborators

Lead sponsor

Memorial Health System

Other

Collaborators

Nexan Inc

Registry information

Acronym: PROSPECT

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 5, 2008
Registry last updated: Feb 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed